CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate recalled
Vascutek is recalling The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, distributed in Puerto Rico. The recall was initiated on 8 Jul 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2542-2021
- FDA event ID
- 88278
- Recalling firm
- Vascutek, Inchinnan, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jul 2021
- FDA classified
- 24 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 8 Jul 2021 | Recall initiated by company | |
| 24 Sep 2021 | Classified by FDA | +78 days |
| 6 Oct 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Product as listed by the FDA
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile. (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm, REF 631809, sterile. (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm, REF 632010, sterile. (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm, REF 632211, sterile
Where it was distributed
Distribution was made to PR and Guam.
Questions about this recall
Why was it recalled?
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Which lots are affected?
To be reported.
Where was it sold?
Distribution was made to PR and Guam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88278| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Instructions for Use (IFU) for: Carotid Patch recalled by Vascutek | Vascutek | Other | PR |
More recalls from Vascutek
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Gelsoft Plus recalled by Vascutek | Vascutek | Labeling Errors | Nationwide |
| Device | CLASS II | The Instructions for Use (IFU) for: Carotid Patch recalled by Vascutek | Vascutek | Other | PR |
| Device | CLASS II | Gelseal Straight Diameter Length Vascular graft prosthesis recalled | Vascutek | Packaging Defects | MI |
| Device | CLASS II | Gelseal Straight Diameter Length Vascular graft prosthesis recalled | Vascutek | Packaging Defects | MI |
| Device | CLASS II | Gelweave (TM) Vascular Prostheses recalled by Vascutek | Vascutek | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,227| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NaviFlex LW Pusher recalled by Boston Scientific | Boston Scientific | Other | Nationwide |
| Device | CLASS II | JenaValve Trilogy Delivery Catheter, Size recalled | Jenavalve Technology | Other | Nationwide |
| Device | CLASS II | Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack recalled | Sarnova HC | Other | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | JenaValve Trilogy Delivery Catheter, Size recalled | Jenavalve Technology | Other | Nationwide |