Great Batch Medical
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000032810 FEI 2183787
- Devices
- 12
- Registrations
- EUDAMEDFDA
- FDA recalls
- 20
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What Great Batch Medical makes
Great Batch Medical manufactures steerable and guiding sheaths for interventional cardiology, including transseptal needles and peelable introducers for vascular access. Their portfolio includes radial access kits for transfemoral and transradial procedures, as well as a sutureless myocardial pacing lead for cardiac rhythm management.
The company’s devices are regulated under FDA Class II and Class III classifications, with authorisations granted through 510(k) clearances and Premarket Approval Applications (PMA). Products are listed in the FDA’s 510(k) and PMA registries, and the manufacturer is based in the United States.
Catalogue
Search and filter all 12 devicesCompany details
- EUDAMED SRN
- US-MF-000032810
- FDA FEI number
- 2183787
- EUDAMED status
- Active
- EUDAMED registered name
- Greatbatch Medical
- Registered address
- 2300 Berkshire Lane North, 55441, Minneapolis, United States
- Website
- www.integer.net
- [email protected]
- Phone
- +1 763 951 8200
- PRRC contact
- Maria Mundaden
FDA recalls
FDA recall records list 20 recalls initiated by Great Batch Medical, the earliest on 2009-09-01 and the most recent on 2017-04-23. By recorded status: 20 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, performance or accuracy 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.
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 23 Apr 2017 Z-2055-2017 Class II Terminated Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.
- 15 Feb 2017 Z-2782-2017 Class II Terminated One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
2016
- 11 Nov 2016 Z-2781-2017 Class II Terminated Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
- 19 Oct 2016 Z-1190-2017 Class II Terminated On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. The 2016 failure rate for this failure exceeds the occurrence rate as defined in the DFMEA.
- 8 Sep 2016 Z-0623-2017 Class II Terminated Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.
- 2 Aug 2016 Z-0367-2017 Class I Terminated On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU).
Full distribution text
- 26 Apr 2016 Z-1882-2016 Class II Terminated Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
- 26 Apr 2016 Z-1883-2016 Class II Terminated Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
- 26 Apr 2016 Z-1884-2016 Class II Terminated Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
2014
- 28 Apr 2014 Z-1614-2014 Class II Terminated Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
Show all 20 recalls
2014
- 31 Jan 2014 Z-1119-2014 Class I Terminated Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004.
Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
Full distribution text
- 31 Jan 2014 Z-1119-2014 Class I Terminated Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004.
Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
2013
- 31 May 2013 Z-1608-2013 Class II Terminated Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire.
- 16 Jan 2013 Z-0751-2013 Class II Terminated Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45 product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.
Full distribution text
2012
- 12 Nov 2012 Z-0611-2013 Class II Terminated Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).
Full distribution text
- 24 Sep 2012 Z-0132-2013 Class II Terminated We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths.
- 6 Sep 2012 Z-2459-2012 Class II Terminated During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.
- 12 Nov 2012 Z-0611-2013 Class II Terminated Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).
2010
- 2 Jul 2010 Z-2294-2010 Unclassified (pre-2012) Terminated The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray are sterile. Infection may result if a sterile field is contaminated by the outer surface of the inner tray.
- 13 May 2010 Z-0287-2011 Unclassified (pre-2012) Terminated The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.
2009
- 1 Sep 2009 Z-0580-2010 Unclassified (pre-2012) Terminated The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.
- 1 Sep 2009 Z-0581-2010 Unclassified (pre-2012) Terminated The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.
Frequently asked questions
How many devices does Great Batch Medical have in the registry?
The registry currently lists 12 devices for Great Batch Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Great Batch Medical's devices?
Among its 12 most recently registered devices, Great Batch Medical has devices listed in EUDAMED (1 device), FDA 510(k) (10 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Great Batch Medical's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Great Batch Medical's devices are Class IIa, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Great Batch Medical?
FDA recall records list 20 recalls initiated by Great Batch Medical, the most recent initiated on 23 Apr 2017. 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 Great Batch Medical in the registry?
The most recently registered devices listed for Great Batch Medical include OptiSeal™ Valved Peelable PTFE Introducer Kit, Z FLEX-270TM STEERABLE SHEATH, MOBICATH BI-DIRECTIONAL GUIDING SHEATH and MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX.