CinchRecalls & reported problems across all models

We found 2 models of Cinch by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 147 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2018 and Jun 9, 2026 — classified as 147 injuries.

The most frequently reported specific device problem is “Migration” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Cinch problems

Cinch models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cinch™ 1194

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  118 reports
• Cinch™ 1194

  STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
  29 reports

Recent Cinch adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD SITE AND WAS HOSPITALIZED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED BOTH ORAL AND IV ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25439160 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD SITE AND WAS HOSPITALIZED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED BOTH ORAL AND IV ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25439159 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S STITCHES WERE NOT HEALING AS EXPECTED. THE PHYSICIAN SUSPECTED AN INFECTION. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED.

  Patient problems: Fluid Discharge

  MAUDE report 25029529 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S STITCHES WERE NOT HEALING AS EXPECTED. THE PHYSICIAN SUSPECTED AN INFECTION. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED.

  Patient problems: Fluid Discharge

  MAUDE report 25023375 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE ANCHORS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026, WHEREIN BOTH ANCHORS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 24916320 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE ANCHORS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN BOTH ANCHORS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 24916314 ↗
• InjuryFeb 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD INCISION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24340963 ↗
• InjuryFeb 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD INCISION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24340960 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24038925 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24038884 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 23910835 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 23910833 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DISCOMFORT AT THE ANCHOR SITE. IT IS UNKNOWN WHICH ANCHOR ATTRIBUTED TO THIS ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Implant Pain

  MAUDE report 23640719 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT THE LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 22986846 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21623866 ↗

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