INPUT™ TS 081102ARecalls & reported problems
Medtronic, Inc. · INTRDCR 081102A 5PK 11CM 8F INPT TS WNDL · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169014459), received between Jul 9, 2018 and Jul 9, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K955785); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component
AN 8F INPUT TS DEVICE WAS INTENDED TO BE USED DURING A PROCEDURE. UPON REMOVAL OF THE 8F INTRODUCER, IT WAS OBSERVED THAT THE TIP OF THE INPUT TS DEVICE WAS BROKEN, LEAVING THE ENTIRE EXTENSION OF THE DEVICE IN THE PATIENT'S FEMORAL VEIN.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 7669165 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K955785. One submission often covers many models, so check the product and lot details in each record.
- Z-0441-2009 · Oct 7, 2008 · Terminated5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilita
- Z-0443-2009 · Oct 7, 2008 · Terminated7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilita
- Z-0442-2009 · Oct 7, 2008 · Terminated6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilita
- Z-0444-2009 · Oct 7, 2008 · TerminatedMedtronic Input TS 7F 11 cm Ref: 071102A Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter throug
Other INTRODUCER, CATHETER devices
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- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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