Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump

FDA device recall Z-1573-2013 · posted 2013-06-24 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.

Action taken

The firm, Medtronic, sent an "Urgent: Medical Device Removal" letter dated May 2013 to its customers. The letter described the product, problem and actions to be taken. Representatives (Rep) are visiting all locations, beginning June 3, 2013, to retrieve devices with a Use By date of 2014 08 14 (August 14, 2014) or sooner. The Rep is leaving a letter with the hospitals to tell them that the Sutureless Connector Intrathecal Catheter connector has been redesigned and that they are removing unused devices. They also do not recommend using any of the old design. An Account Specific Customer Confirmation Form will be completed by the Rep. A copy of the completed form will be left with the Hospital along with the Urgent Medical Device Removal letter. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.

Root cause

Device Design

Status

Terminated

Product code

LKK

Quantity affected

115,722 total

Distribution

Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador,

Date initiated

2013-06-03

Date posted

2013-06-24

Date terminated

2014-04-07

Location

Minneapolis, MN