Medtronic Passive Planar Blunt Probe Recalled Due to Sharp Tip Defect
Medtronic is recalling 18 Passive Planar Blunt Probes because they were manufactured with sharp tips instead of blunt tips. The devices are used in navigated surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a surgical instrument with a sharp tip instead of a blunt tip, which poses a risk of harm during use, but the source text does not report any injuries or illnesses.
Plain-English summary
Medtronic Navigation, Inc. is recalling 18 units of the Passive Planar Blunt Probe, Part Number 960-556, Lot 150223. The recall is due to a manufacturing defect where the probes were produced with sharp tips rather than the intended blunt tips. These probes are optically tracked, reusable instruments used for patient registration and palpating brain tissue during navigated surgery. The affected units are included in specific part number kits (9732540, 9732622, 9733174, 9733935) and may be packaged with other instruments or in holding trays.
The recall covers distribution to the United States states of California, Missouri, Louisiana, and Pennsylvania, as well as international distribution to Ireland. The agency has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the defect involves a physical change to the instrument's tip that differs from its design specifications.
The recalled product
- Product
- Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically…
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot number 150223
Distribution
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