St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Recall
- Recall Number
- Z-0213-2018
- Event Number
- 77470
- Firm
- Sterilmed Inc
- FEI Number
- 3011276773
- Product Code
- DYB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 2, 2017
- Posted
- December 29, 2017
- Terminated
- July 29, 2019
- Address
- 5010 Cheshire Pkwy N, Ste 2, Minneapolis, MN, 55446-4101
Description
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Inadequate seal due to lack of adhesive glue
Sterilmed sent an Urgent Medical Device Recall letter dated June 12, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory to determine if affected products are on hand, complete and return the Business Reply Form, share information with appropriate staff in facility, attach copy of this notification to quarantined product, and return affected product to Sterilmed. For questions contact Sterilmed's Customer Care Team at 888-541-0078.
US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
112 devices