This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

The FDA is aware that Glycar SA has issued a letter to affected customers recommending certain SJM Pericardial Patches be removed from where they are used or sold:

  • Device Name: SJM Pericardial Patch
  • Model: C0914
  • Lot Number: T2502257
  • UDI: 05414734007276

What to Do

Identify and cease use of affected products with lot number T2502257 immediately.

On October 17, 2025, Glycar SA sent all affected customers a letter recommending the following actions:

  • Identify and quarantine any affected products with lot number T2502257 in your possession.
  • Cease use of the affected device immediately.
  • Share this notice with applicable personnel within your institution.
  • Abbott (US distributor) will coordinate and arrange for return and replacement of affected units.
  • Complete and return the attached Acknowledgment Form within 5 business days to confirm receipt of this notice

Reason for Recall

Glycar SA stated that a specific batch of the SJM Pericardial Patch was identified as having a deviation in one of the in-process quality control steps (referred to as impacted lot).  All other lots you may have in your inventory are unaffected and fit for use.

The deviation was limited to only one lot of devices that were shipped. The impacted lot may not meet the required tensile strength specification. Possible change in tensile strength is not detectable to the user intraoperatively.

Postoperative loss of the patch’s mechanical properties causing dehiscence or rupture may require reintervention or reoperation, depending on the clinical indication that the patch was used for.

As of October 17, 2025, Glycar SA has reported no serious injuries or deaths associated with this issue.

Device Use

The SJM Pericardial Patch is used for pericardial closure and cardiac and great vessel reconstruction and repair.

Additional FDA Resources:  

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event 
reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.