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VersaOne recallZ-1465-2023 · Covidien LP · initiated Mar 22, 2023

Class II Open, Classified All recalls posted in April 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.

FDA root cause category: Process control

What the company is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated March 2023 was sent to customers. Customer Actions: Our records show that your facility has received the impacted product. Medtronic requests that you take the following actions: " Identify and quarantine any used and unused impacted product. Please refer to Attachment A: Impacted Serial Number Lists for a list of affected products. For verifying the respective product and serial number on the device and packaging please refer to Attachment B. " Sterilize all used devices as per your standard decontamination protocol prior to returning used cannulas. Utilization of appropriate personal protective equipment is advisable during decontamination of the device. " Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. " Complete the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. " Forward this notification to any entities within your organization or to any other organization where the potentially affected product has been transferred or further distributed. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) " Medtronic Technical Services at 1-800-962-9888, option 2 to provide information regarding those events. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative.

Recall details

Recall number
Z-1465-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Mar 22, 2023
Posted by the FDA
Apr 26, 2023
Recalling firm
Covidien LP
Quantity
1 units
Product code
GCJ
FDA submissions
K201805
Distribution
Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.

Product description

VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS

Code information (models, lots, serial numbers)

UDI-DI: 10884521784062; Serial Numbers: C21RXG0005

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K201805 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92004).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page