Shiley TTHRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884522042994), received between Apr 5, 2019 and Feb 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 reports).

23 other recalls cover devices cleared under the same FDA submission (K962173); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Component Missing

  IT WAS REPORTED THAT PRIOR TO USAGE, THE TRACH TUBE HOLDER HAD MISSING HOOK-AND-LOOP FASTENER. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THERE WAS A PIECE OF VELCRO MISSING FROM ONE END OF THE TRACH TUBE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469617 ↗
• MalfunctionJan 28, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WERE TWO VELCRO PART OF THE TRACHEOSTOMY TUBE HOLDERS DID NOT ADHERE SECURELY AND DETACHED WHEN USE. THE HOLDER WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206244 ↗
• MalfunctionJan 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WERE TWO VELCRO PART OF THE TRACHEOSTOMY TUBE HOLDERS DID NOT ADHERE SECURELY AND DETACHED WHEN USE. THE HOLDER WAS REPLACED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193776 ↗
• MalfunctionJun 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FIXATION STRAP/STRING (VELCRO PART) WHICH WAS A FIXING STRING ATTACHED TO THE END OF THE SOFT HOLDER OF THE ENDOTRACHEAL TUBE WAS DETACHED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367683 ↗
• MalfunctionFeb 25, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN TRYING TO ATTACH THE PRODUCT ONTO THE NECK FLANGE OF THE TRACHEOTOMY TUBE, THE TAPERED OR STRIPPED PART FOR ATTACHMENT WAS FOUND TO BE TORN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378874 ↗
• MalfunctionJan 22, 2020Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, THE UNIT TAPE WAS ATTACHED ON ONE SIDE ONLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9617168 ↗
• MalfunctionSep 16, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE ROLLED PART CONNECTED TO THE NECK FLANGE OF THE DEVICE WAS FOUND TO BE COULD NOT BE ATTACHED TO THE OPPOSING SIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9070165 ↗
• MalfunctionJul 18, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO APPLYING THE PRODUCT ON A PATIENT AFTER OPENING THE PACKAGE, THERE WERE PERFORATIONS AT THE PART THAT SHOULD HAVE BEEN SEWN, BUT THERE WAS NO THREAD APPLIED TO IT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8803758 ↗
• MalfunctionJun 11, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S HOLDER BROKE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689865 ↗
• MalfunctionApr 5, 2019Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE FASTENER PART HAD COME APART. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8488576 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962173. One submission often covers many models, so check the product and lot details in each record.

• Z-2174-2012 · Jul 18, 2012 · Terminated
  Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product
• Z-1465-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended
• Z-1464-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1469-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for byp
• Z-1490-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1473-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, C
• Z-1478-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1491-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Inten
• Z-1470-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1489-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1481-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1472-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1462-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1477-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton,
• Z-1468-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa

…and 8 more.