Cook Medical recalled all unexpired lots of Transseptal Needles and Transseptal Needles with Catheter, used in heart procedures and made over a nearly five-year period, after customers found rust on needles.
“Use of affected products could result in increased procedural time and inflammatory reactions, including systemic reactions which may lead to permanent impairment or death,” the company-written, FDA-posted recall notice said.
Cook Medical says the Transseptal Needle is “intended for transseptal left heart access in both diagnostic and interventional procedures” while the Transseptal Needle with Catheter is “intended to facilitate transseptal entry into the left atrium.”
Both “were found to have rust internally, externally or both.”
Cook says it’s received “four complaints where the presence of rust was identified prior to patient contact. However, please be advised that the presence of rust may go undetected by the user.”
The recalled Transseptal Needle’s part Nos. are TSNC-18-71.0 and TSNC-19-56.0, with respective order Nos. G02364 and G02365. The needle with catheter’s part No. is TSN-17-75.0-ENDRYS with order No. G19261. They were made from Oct. 2, 2016 through July 22, 2021 and all lot numbers are involved.
What you should do now
Medical facilities and professionals in the United States, Central America, the Caribbean and South America should return the needles to Cook Medical. If you’re in the U.S. and in Latin America, call 800-457-4500, press option No. 5, then ext. 151090 for a return goods authorization number and return address.
If these needles or a drug causes a problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
Only then do you contact the company. In this case, that would be Cook Medical via email at CustomerRelationsNA@cookmedical.com or by phone at 800-457-4500 or 812-339-2235, Monday through Friday, 7:30 a.m. to 5 p.m., Eastern time.