Medtronic Recalls 6F Taiga Guiding Catheters Due to Tip Detachment
Medtronic is recalling 15,923 units of 6F Taiga Guiding Catheters distributed in Japan due to reports of tip detachment and splitting.
What this means for you
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 involves a medical device with a mechanical defect (tip detachment/splitting) that poses a risk of harm during use, but the source text does not report any specific injuries, hospitalizations, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc is recalling 15,923 units of the 6F Taiga Guiding Catheter. The recall was initiated due to complaints regarding the detachment and/or splitting of the catheter tip. The affected products were distributed in Japan.
The source text does not specify the exact dates of distribution or the specific medical facilities where these devices were used. The recall number is Z-1207-2018.
Healthcare providers and patients should check their inventory and records for the specific lot and serial numbers listed in the official recall notice. If a device with a detached or split tip has been used, medical professionals should follow their institution's protocols for reporting adverse events and managing patient care.
The recalled product
- Product
- 6F Taiga Guiding Catheter
- Manufacturer
- Medtronic Inc
- Affected units
- 15,923
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 (20)
- Lot/Serial Number's: 0008104881
- 0008185945
- 0008448845
- 0008498609
- 0008591678
- 0008603130
- 0008128237
- 0008185937
- 0008359341
- 0008381347
- 0008520748
- 0008572204
- 0008584614
- 00 887489
- 0008132544
- 0008143685
- 0008153935
- 0008176874
- 0008181991
- 0008189749
Distribution
Distribution scope not specified by the agency.
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