VersaOne recallZ-1464-2023 · Covidien LP · initiated Mar 22, 2023
Open, Classified
Is my device affected?
- 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.
- 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.
- 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-1464-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 22, 2023
- Posted by the FDA
- Apr 26, 2023
- Recalling firm
- Covidien LP
- Quantity
- 51 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 11mm Standard, Model Number RC11STS
Code information (models, lots, serial numbers)
UDI-DI: 10884521784048; Serial Numbers: C20RSL0083 C20RSL0085 C20RSL0086 C20RSL0087 C20RSL0088 C20RSL0062 C20RSL0063 C20RSL0071 C20RSL0072 C20RSL0073 C20RSL0074 C20RSL0075 C20RSL0076 C20RSL0070 C21RSJ0012 C20RSL0066 C20RSL0080 C20RSL0095 C20RSL0098 C20RSL0077 C20RSL0078 C20RSL0097 C20RSJ0002 C20RSJ0003 C20RSJ0004 C21RSJ0001 C21RSJ0002 C21RSJ0003 C21RSJ0004 C21RSJ0005 C21RSJ0006 C21RSJ0009 C21RSJ0010 C21RSJ0011 C21RSJ0018 C21RSJ0019 C21RSJ0020 C21RSJ0021 C21RSJ0022 C21RSK0026 C21RSK0027 C21RSK0028 C21RSJ0030 C21RSK0001 C21RSK0002 C21RSJ0013 C21RSJ0014 C21RSJ0015 C21RSJ0016 C21RSK0015 C21RSK0025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VersaOne RC11STSCovidien LP · Laparoscope, general & plastic surgery1 recall1 report
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.
- VersaOne RC8STSCovidien LP · Laparoscope, general & plastic surgery1 recall2 reports
- VersaOne RC12STSCovidien LP · Laparoscope, general & plastic surgery1 recall0 reports
- VersaOne RSEALCovidien LP · Laparoscope, general & plastic surgery19 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92004).
- Z-1463-2023 · Open, ClassifiedVersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
- Z-1465-2023 · Open, ClassifiedVersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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