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Neuron Max 088 Long Sheath (2013-09-19)
- Starting date:
- September 19, 2013
- Posting date:
- November 29, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36889
Recalled Products
Neuron Max 088 Long Sheath
Reason
Penumbra has become aware of complaints involving devices where the operator complained of damage to the tip of the Neuron Max MP catheter after removal from the packaging. Upon evaluation of the returned devices, Penumbra confirmed that the polymer at the distal tip of the device had been damaged. Further investigation determined that the sticker adhesive used to secure the packaging mandrel to the packaging card was less sticky then previous lots of stickers.
Affected products
Neuron Max 088 Long Sheath
Lot or serial number
F31580
Model or catalog number
PNML6F088804M
Companies
- Manufacturer
-
Penumbra Inc.
1351 Harbor Bay Parkway
Alameda
94502
California
UNITED STATES