Hospitals and distributors should stop using and quarantine affected Arrow guidewires and catheter kits because their coating can detach and release particles into the bloodstream, according to an FDA early alert posted Nov. 10.
Arrow International, a Teleflex subsidiary, is removing specified lots of products containing hydrophilic-coated spring wire guides. The affected range includes standalone marked guidewires and certain pressure-injectable PICC and JACC catheter products.
Teleflex says the coating can swell unevenly when hydrated with saline, clump and detach. The released material can obstruct blood vessels, with potential consequences including tissue injury, stroke or death. Arrow had reported no serious injuries or deaths associated with the issue as of Nov. 5, the FDA said.
Match the product code and batch
The manufacturer's field safety notice, EIF-000614, lists affected product codes and batch numbers in Appendix 2, on pages 5 and 6. Match both against inventory. The broad product name alone does not establish whether a particular package is included.
Facilities with affected stock should contact Teleflex to arrange its return. Distributors should pass the notice to customers who received affected stock. Teleflex asks facilities to return its acknowledgment form even if they have no affected product. Its notice says it will issue a credit note after receiving returned affected units.
The manufacturer recorded 17 complaints involving the guidewire coating as of Oct. 27, with no reports of injury or death at that point.
Guidewires help clinicians position catheters. A 2019 review in the Journal of Clinical Medicine explains that hydrophilic wires become slippery when wet, reducing resistance as other devices move over them.
U.S. customers can reach Teleflex at 1-866-396-2111 or Recalls@teleflex.com.
