Urgent Medical Device Recall: Medtronic
Medtronic has initiated a voluntary recall for specific production lots of Shiley™ Adult Flexible Tracheostomy Tubes with TaperGuard™ Cuff and Cuffless with Disposable or Reusable Inner Cannulas.
ISSUE:
This recall follows reports from customers that the device connector in some instances is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories.
POTENTIAL RISK:
While no serious patient harm was associated with these devices, dyspnea, a delay to treatment while an alternate device was obtained, and minor tissue injury and bleeding were reported. There may exist the potential for respiratory failure; however, no reports of this occurrence have been reported to Medtronic.
Actions Required:
1. REVIEW your inventory for affected product.
2. SEGREGATE and QUARANTINE all on-hand product per the Items Impacted table above.
3. COMMUNICATE this notice to clinical staff through safety huddles to ensure awareness of this product issue.
4. CONTACT your IMS Sales Representative or Customer Service to discuss next steps for product returns.
Please review the required actions by Medtronic for complete details.