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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting."
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.
Related recalls
Same manufacturer · Medtronic Inc
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- CriticalMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- SevereMedtronic Vascular Recalls Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09
- SevereMedtronic Recalls 10 Units of Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09
- SevereMedtronic Recalls Six Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09
- ModerateMedtronic Launcher Guiding Catheter Recalled for Labeling Errors
FDA (Devices) · 2013-07-03
- SevereMedtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss
FDA (Devices) · 2019-10-09