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Ela Medical, Inc.

Also registered as Elamedical

United StatesFDA applicant, unverified

Devices
44
FDA recalls
11

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue44

Newest first, rows 1-44 of 44

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FDA recalls11

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

Showing the 10 most recent of 11 recalls.

  • 2011

    • 2 May 2011 Z-2609-2011 Unclassified (pre-2012) Terminated On February 28, 2011, the company discovered that since the beginning of the US commercial distribution of Paradym DR 8550 and Paradym VR 8250 ICDs in October 2010, the devices included an incorrect version of the Patient Booklet. The company determined that there is no risk of adverse event associated with this labeling error. Distribution: Nationwide Distribution including AL, AZ, AR, CA, CO, CT, FL, GA, IA, MA, MI, MO, MS, NJ, NY, NC, OH, OK, PA, SC,A TN,T…
      Full distribution text Nationwide Distribution including AL, AZ, AR, CA, CO, CT, FL, GA, IA, MA, MI, MO, MS, NJ, NY, NC, OH, OK, PA, SC,A TN,T X, and WA.
      Submission number: P980049S050

  • 2010

    • 7 Jun 2010 Z-2579-2010 Unclassified (pre-2012) Terminated The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and to deliver further therapy. The software anomaly could only occurs under a specific sequence of events. Distribution: Nationwide Distribution in the states of AZ, CA, FL, IA, LA, MA, MS,MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, and VA. Submission number: P060027

  • 2008

    • 23 Sep 2008 Z-2235-2009 Unclassified (pre-2012) Terminated Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew. Distribution: Nationwide Distribution -- USA, including states of AL, AZ, CA, CO, CT, FL, GA, KS, KY, LA, MA, MI, NC, NJ, OH, OK, SC,…
      Full distribution text Nationwide Distribution -- USA, including states of AL, AZ, CA, CO, CT, FL, GA, KS, KY, LA, MA, MI, NC, NJ, OH, OK, SC, TN, and TX.
      Submission number: P950029

  • 2005

    • 25 Oct 2005 Z-0266-06 Unclassified (pre-2012) Terminated Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process. Distribution: Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC, Submission number: P950029S017
    • 25 Oct 2005 Z-0267-06 Unclassified (pre-2012) Terminated Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process. Distribution: Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC, Submission number: P950029S017
    • 19 Jul 2005 Z-1587-05 Unclassified (pre-2012) Terminated Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function. Distribution: Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI. Submission number: P980049/S3
    • 19 Jul 2005 Z-1597-05 Unclassified (pre-2012) Terminated Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function. Distribution: Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI. Submission number: P980049/S6
    • 19 Jul 2005 Z-1598-05 Unclassified (pre-2012) Terminated Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function. Distribution: Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
    • 25 Jan 2005 Z-0801-05 Unclassified (pre-2012) Terminated A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks. Distribution: AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina. Submission number: P970024
    • 25 Jan 2005 Z-0802-05 Unclassified (pre-2012) Terminated A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks. Distribution: AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina. Submission number: P970024
Show all 11 recalls

  • 2004

    • 21 Oct 2004 Z-0176-05 Unclassified (pre-2012) Terminated Alto Implantable Defibrillators Models 614 and 615. These models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion. Distribution: Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed…
      Full distribution text Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed from the US to foreign consignees. 95 physicians received the recalled product. ELA Medical has contacted physicians who follow patients implanted with the devices that are the subject of the correction. It should be noted that in many cases, the physician following the patient is not the physician who implanted the device. Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.
      Submission numbers: P980049/S3, P980049/S6

Frequently asked questions

How many devices does Ela Medical, Inc. have in the registry?

The registry currently lists 44 devices for Ela Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ela Medical, Inc.'s devices?

Among its 44 most recently registered devices, Ela Medical, Inc. has devices listed in FDA 510(k) (44 devices).

What risk classes do Ela Medical, Inc.'s devices fall under?

Among its 44 most recently registered devices, the classes recorded for Ela Medical, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Ela Medical, Inc.?

FDA recall records list 11 recalls initiated by Ela Medical, Inc., the most recent initiated on 2011-05-02. 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 Ela Medical, Inc. in the registry?

The most recently registered devices listed for Ela Medical, Inc. include PACING LEAD #PMA F 860, OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004, LEAD MODELS MUM 1260, MUM 1290 and FOCUS J81F, J83F, J41F, J43F PACING LEADS.

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