Vascutek recalled 37,430 Gelsoft Plus and Gelweave vascular prostheses distributed nationwide in the United States after discovering the devices were labeled with an extra month of shelf life. The expiry date was calculated from packaging rather than gel impregnation. Healthcare providers and patients should stop using the devices immediately and follow recall instructions.
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vascutek, Ltd. or your healthcare provider for instructions. Notification method: Letter
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Gelsoft Plus and Gelweave vascular prostheses are implanted during vascular repair surgeries to replace or bypass diseased arteries.
The expiry date was miscalculated because labeling relied on packaging rather than the gel impregnation manufacturing date. This could lead to use of expired devices or confusion about shelf life.
This recall is not part of a broader industry pattern.
Hospitals must audit inventory and notify patients. Replacements or refunds may cause procedural delays. No injuries have been reported yet.
Expiry and manufacturing data are on device packaging and labeling; recall letters provide specifics.
Refund or replacement processing typically 4-8 weeks after notification.
Retain recall letter, packaging photos, model numbers, receipts, and all correspondence.
Gelsoft Plus devices with REF numbers including 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE among others. Gelweave devices include REF numbers such as 736038E, 736036E, 736034E, 736032E, 736030E, 736028E, 736026E, 736024E, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, and related variants. Total quantity recalled: 37,430. Distribution: United States nationwide.
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