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Boston Scientific Scimed, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
39
FDA recalls
44

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Boston Scientific Scimed, Inc. makes

Boston Scientific Scimed, Inc. manufactures biliary, tracheobronchial, and enteral endoprostheses, including pre-mounted stent systems like the NIROYAL BILIARY PREMOUNTED STENT SYSTEM and the WALLSTENT BILIARY ENDOPROSTHESIS. Their portfolio also includes delivery systems for these stents, such as the UNISTEP PLUS and Schneider GuideZilla Softip guiding catheters. Diagnostic and imaging catheters, like the Schneider GuideR Softip and Laguna Softip diagnostic catheters, are also part of their offerings. Modifications to existing devices, such as the Express Biliary LD stent system and Atlantis PV imaging catheter, are regularly updated.

The company’s products are regulated under FDA pathways, with devices classified as Class II and Class III. Endoprostheses and related delivery systems are authorised via 510(k) clearances and Premarket Approval Applications (PMAs). These devices are listed in the FDA’s regulatory registries, reflecting compliance with US medical device regulations.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue39

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FDA recalls44

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 44 recalls initiated by Boston Scientific Scimed, Inc., the earliest on 2003-03-17 and the most recent on 2005-08-05. By recorded status: 44 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 44 recalls.

  • 2005

    • 5 Aug 2005 Z-0299-06 Unclassified (pre-2012) Terminated Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear. Distribution: OUS includes countries of Chile, Japan, Netherlands and Taiwan. Within the US to: AK, AL, AR, AZ, CA, CO, CT, FL, GA,…
      Full distribution text OUS includes countries of Chile, Japan, Netherlands and Taiwan. Within the US to: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA and WI
      Submission number: K964284
    • 5 Aug 2005 Z-0300-06 Unclassified (pre-2012) Terminated Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear. Distribution: OUS includes countries of Chile, Japan, Netherlands and Taiwan. Within the US to: AK, AL, AR, AZ, CA, CO, CT, FL, GA,…
      Full distribution text OUS includes countries of Chile, Japan, Netherlands and Taiwan. Within the US to: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA and WI
      Submission number: K901659
    • 19 Apr 2005 Z-0931-05 Unclassified (pre-2012) Terminated Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength. Distribution: The product was distributed to hospitals nationwide.

  • 2004

    • 29 Oct 2004 Z-0454-05 Unclassified (pre-2012) Terminated The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon Distribution: Throughout United States and into 15 other countries. Submission number: K033441
    • 9 Jul 2004 Z-1340-04 Unclassified (pre-2012) Terminated Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use. Distribution: Inside the US only. Submission number: K992510
    • 1 Jul 2004 Z-1052-04 Unclassified (pre-2012) Terminated On a few occasions the balloon has failed to deflate within one minute after deployment of the stent. Distribution: Nationwide and Canada Submission number: P030025
    • 24 May 2004 Z-0432-06 Unclassified (pre-2012) Terminated Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style. Distribution: Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom Submission number: K010874
    • 24 May 2004 Z-0433-06 Unclassified (pre-2012) Terminated Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style. Distribution: Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom Submission number: K010874
    • 14 May 2004 Z-0440-06 Unclassified (pre-2012) Terminated One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package. Distribution: Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. The following countries were contacted regarding the recall and all…
      Full distribution text Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates
      Submission number: K032025
    • 13 Feb 2004 Z-0729-04 Unclassified (pre-2012) Terminated Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain. Distribution: The product was shipped to consignees in Florida in the United States.
Show the 25 most recent of 44 recalls

  • 2003

    • 20 Aug 2003 Z-0030-04 Unclassified (pre-2012) Terminated Some of the recalled catheters have a component that has levels of pyrogens above specification. Distribution: The recalled products were distributed to consignees located nationwide in the United States. Submission number: P860019
    • 20 Aug 2003 Z-0031-04 Unclassified (pre-2012) Terminated Some of the recalled catheters have a component that has levels of pyrogens above specification. Distribution: The recalled products were distributed to consignees located nationwide in the United States. Submission number: P860019
    • 20 Aug 2003 Z-0032-04 Unclassified (pre-2012) Terminated Some of the recalled catheters have a component that has levels of pyrogens above specification. Distribution: The recalled products were distributed to consignees located nationwide in the United States. Submission number: P860019
    • 1 Aug 2003 Z-1189-03 Unclassified (pre-2012) Terminated Some of the recalled catheters may be in pouches with incomplete seals. Distribution: The product was shipped nationwide in the United States.
    • 16 Jul 2003 Z-1123-03 Unclassified (pre-2012) Terminated There is an Increased potential for broken struts of the stents. Distribution: The products were shipped to consignees located nationwide in the United States. Submission number: P020009
    • 1 Jul 2003 Z-1096-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States. Submission number: K021735
    • 1 Jul 2003 Z-1097-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States. Submission number: K021735
    • 1 Jul 2003 Z-1098-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States. Submission number: K021735
    • 1 Jul 2003 Z-1099-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States. Submission number: K021735
    • 1 Jul 2003 Z-1100-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States. Submission number: K021735
    • 1 Jul 2003 Z-1101-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States. Submission number: K021735
    • 1 Jul 2003 Z-1102-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States.
    • 1 Jul 2003 Z-1103-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States. Submission number: K021735
    • 1 Jul 2003 Z-1104-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States. Submission number: K021735
    • 1 Jul 2003 Z-1105-03 Unclassified (pre-2012) Terminated Some of the product pouches have holes in the seals. Distribution: The recalled products were shipped to hospitals located nationwide in the United States. Submission number: K021735

Frequently asked questions

How many devices does Boston Scientific Scimed, Inc. have in the registry?

The registry currently lists 39 devices for Boston Scientific Scimed, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Boston Scientific Scimed, Inc.'s devices?

Among its 39 most recently registered devices, Boston Scientific Scimed, Inc. has devices listed in FDA 510(k) (34 devices) and FDA PMA (5 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Boston Scientific Scimed, Inc.'s devices fall under?

Among its 39 most recently registered devices, the classes recorded for Boston Scientific Scimed, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Boston Scientific Scimed, Inc.?

FDA recall records list 44 recalls initiated by Boston Scientific Scimed, Inc., the most recent initiated on 2005-08-05. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Boston Scientific Scimed, Inc. in the registry?

The most recently registered devices listed for Boston Scientific Scimed, Inc. include NIROYAL BILIARY PREMOUNTED STENT SYSTEM, WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM, SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER and WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.