Recall Z-0287-2011 ยท DTB Permanent Pacemaker Electrode
Greatbatch Medical
enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
| Date | Nov 2, 2010 (initiated May 13, 2010) |
| Status | Terminated |
| Reason | The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode. |
| Root cause | Employee error |
| Action | Greatbatch Medical issued an Urgent Medical Device Recall letter dated May 13, 2010 to their distributor. The letter described the problem and product involved, and gave the action required which included: 1) immediately discontinue distribution of the units and return any unused units to Greatbatch Medical. 2) Reconcile medical recordsbetween BSC and Greatbatch Medical to confirm implant data 3) Confirm pulse generator type (bipoloar, unipolar, or unknown) used with each serial number listed Greatbatch will work with customers to contact physicians as necessary regarding patient monitoring. G |
| Quantity | 34 |
| Distribution | Worldwide Distribution: to USA and Europe, through distributor in MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.