CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report
Gelseal Straight Diameter Length Vascular graft prosthesis recalled
Vascutek is recalling Gelseal Straight Diameter Length Vascular graft prosthesis is an implanted device, distributed in Michigan. The recall was initiated on 15 May 2015 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-1913-2015
- FDA event ID
- 71305
- Recalling firm
- Vascutek, Inchinnan
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2015
- FDA classified
- 26 Jun 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 15 May 2015 | Recall initiated by company | |
| 26 Jun 2015 | Classified by FDA | +42 days |
| 8 Jul 2015 | 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
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Where it was distributed
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Questions about this recall
Why was it recalled?
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Which lots are affected?
Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215
Where was it sold?
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
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 71305This product is part of a recall event; the main page for the event is Gelseal Straight Diameter Length Vascular graft prosthesis recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Gelseal Straight Diameter Length Vascular graft prosthesis recalled | Vascutek | Packaging Defects | MI |
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 | The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate recalled | Vascutek | Other | PR |
| 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
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|---|---|---|---|---|---|
| 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 |