Vascutek, Ltd. Recalls Gelsoft Plus and Gelweave Vascular Devices Due to Incorrect Shelf Life Labeling

What Happened

Vascutek, Ltd. has initiated a voluntary recall of gelatin-sealed woven polyester prostheses used for vascular repair. The devices were incorrectly labeled with an additional month of shelf life. According to the manufacturer, the device expiry should have been calculated from the date of gel impregnation (the date of manufacture); however, it was incorrectly calculated from the date of device packaging.

Which Products Are Affected

This recall affects approximately 37,430 units distributed nationwide across the United States. Affected products include various models of the following brands:

• Gelsoft Plus: Includes any item number ending in ‘E-B’ (e.g., 631206PE-B). Specific REF numbers include 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, and others listed in the official recall notice.
• Gelweave: Includes any item number ending in ‘E-B’ (e.g., 7320128/10RMEE-B). Specific REF numbers include 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, and many others.

Recall Number: Z-1492-2026
Distribution Scope: Nationwide distribution including FL, PA, TX, NC, NY, CA, NJ, OH, MI, DC, CO, VA, GA, IL, OR, ND, VT, MS, MA, IN, WA, AZ, MN, MD, IA, OK, MO, AL, WI, LA, AR, TN, CT, ME, NE, SC, KS, NV, KY, RI, WV, UT, MT, ID, AK, NH, DE, NM, SD, HI, and WY.

What You Should Do

Vascutek, Ltd. initiated the recall by sending notification letters to affected customers. Healthcare providers and facilities should immediately review their inventory for the affected REF and item numbers. If you have these products in stock, follow the specific instructions provided in the manufacturer’s letter regarding the return or disposal of the devices.

Why This Matters

The significance of this recall lies in the potential for devices to be used beyond their validated stability period. Incorrect shelf life labeling can lead to the use of prostheses that may not perform as intended during critical vascular repair procedures.

Source

FDA - Recall Event ID: 98338