Z-1637-2015Class I

Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code...

Name: Z-1637-2015 Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code...
Creator: Synovis Surgical Innovations, Inc.
Published: 2015-05-02
License: https://open.fda.gov/license/

SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) / initiated 2015-05-02 / Terminated

FDA source

Synovis Surgical Innovations, Inc. began a recall of Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm... on 2015-05-02. FDA classified it as Class I and gives the reason as "Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1637-2015
Classification: Class I
Status: Terminated
Initiated: 2015-05-02
Posted: 2015-05-29
Terminated: 2016-02-18
Recalling firm: SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)
Product: Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Product code: DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Reason for recall: Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
FDA root cause: Under Investigation by firm
Action: The firm, Baxter, sent an "Urgent Product Recall" letter dated 5/2/2015 via USPS overnight delivery to its customers. The letter identified the affected product, problem and actions to be taken. The customers were instructed to immediately discontinue use and segregate the affected product, locate and remove all affected product from your facility and to return it to Baxter. Customers are to contact Baxter Healthcare Center, 888-229-0001, for Service to arrange for return and credit. In addition, the customers were to complete and return the Customer Reply Form by faxing to 224-270-5457 or emailing to [email protected]. If you have any questions, contact Director, Quality at 651-796-7543 or email: [email protected].
Quantity in commerce: 3,974
Distribution: Nationwide Distribution.
Product codes and lots: all lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1637-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1637-2015	Class I	Terminated	Voluntary: Firm initiated	2015-06-10	2015-05-29

Product code DXZ

K142461Class IIVASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc. / cleared 2014-11-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)