Recall StatusOpen, Classified
Date Initiated2023-08-22
Product Quantity408
Reason for Recall
Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.
Firm Action
On 8/22/23 Medtronic mailed recall notices to risk managers and directors of respiratory care informing them of the following:
1) Discontinue use, quarantine, and return affected devices to the firm.
2) Complete and return the customer confirmation form via email to it to
[email protected].
3) Forward the notice to all those who need to be aware within your organization or to any organization where the potentially affected product with the specified serial numbers has been transferred or distributed.
If you have any questions regarding this communication, contact customer service at 800-962-9888, Option 2. Quality problems can be reported to Quality Assurance at 800-255-6774 option 4.
Root Cause
Component design/selection
Distribution Pattern
US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN.
OUS: El Salvador, Sweden, Canary Islands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.