Shiley 6DCFSRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884522006620), received between May 8, 2018 and Jun 19, 2020 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 23, 2026Open, Classified

   Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

   Z-2653-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S TIP HAD SHARP EDGES IRRITATING THE THROAT OF THE PATIENT. IRRITATION DESCRIBED AS SCRATCHY WHEN THE NECK OR HEAD WAS MOVING AND UNEASY TO SPEAK. THE PATIENT'S TUBE WAS REPLACED WITH NEW ONE TO RESOLVE THE ISSUE.

  Patient problems: Injury

  MAUDE report 10176237 ↗
• MalfunctionApr 21, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD DIMENSIONAL ISSUE- INNER CANNULA WAS LONGER THAN THE OUTER CANNULA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9984436 ↗
• InjuryJan 6, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, IT WAS STATED THAT THE PATIENT EARLIER IN THE DAY AND PATIENTS AIRWAY WAS PATENT WITH A TRACH, AND GOT CALLED BACK BECAUSE THE PATIENT SELF DECANNULATED THEMSELVES AND UPON ASSESSMENT OF THE TRACH, THE TIP OF THE TRACH WAS COMPRESSED. PATIENT SELF DECANNULATED.

  Patient problems: Extubate

  MAUDE report 9551306 ↗
• InjuryDec 4, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICES' INNER CANNULAS EXTEND TOO FAR PAST THE END OF THE TRACHEOSTOMY TUBE WHICH INDUCED DISCOMFORT (CAUSED PAINFUL AND SCRATCHY FEELING) AS WELL AS INCREASED BLEEDING (DID NOT EXCEED 500CC) AND DRAINAGE. IT WAS INDICATED THAT RECANNULATION/DECANNULATION WAS NECESSARY.

  Patient problems: Blood Loss; Discomfort; Extubate

  MAUDE report 8131666 ↗
• InjuryDec 4, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICES' INNER CANNULAS EXTEND TOO FAR PAST THE END OF THE TRACHEOSTOMY TUBE WHICH INDUCED DISCOMFORT (CAUSED PAINFUL AND SCRATCHY FEELING) AS WELL AS INCREASED BLEEDING (DID NOT EXCEED 500CC) AND DRAINAGE. IT WAS INDICATED THAT RECANNULATION/DECANNULATION WAS NECESSARY.

  Patient problems: Blood Loss; Discomfort; Extubate

  MAUDE report 8131663 ↗
• InjuryDec 4, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICES' INNER CANNULAS EXTEND TOO FAR PAST THE END OF THE TRACHEOSTOMY TUBE WHICH INDUCED DISCOMFORT (CAUSED PAINFUL AND SCRATCHY FEELING) AS WELL AS INCREASED BLEEDING (DID NOT EXCEED 500CC) AND DRAINAGE. IT WAS INDICATED THAT RECANNULATION/DECANNULATION WAS NECESSARY.

  Patient problems: Blood Loss; Discomfort; Extubate

  MAUDE report 8131649 ↗
• InjuryDec 4, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICES' INNER CANNULAS EXTEND TOO FAR PAST THE END OF THE TRACHEOSTOMY TUBE WHICH INDUCED DISCOMFORT (CAUSED PAINFUL AND SCRATCHY FEELING) AS WELL AS INCREASED BLEEDING (DID NOT EXCEED 500CC) AND DRAINAGE. IT WAS INDICATED THAT RECANNULATION/DECANNULATION WAS NECESSARY.

  Patient problems: Blood Loss; Discomfort; Extubate

  MAUDE report 8131639 ↗
• InjuryDec 4, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICES' INNER CANNULAS EXTEND TOO FAR PAST THE END OF THE TRACHEOSTOMY TUBE WHICH INDUCED DISCOMFORT (CAUSED PAINFUL AND SCRATCHY FEELING) AS WELL AS INCREASED BLEEDING (DID NOT EXCEED 500CC) AND DRAINAGE. IT WAS INDICATED THAT RECANNULATION/DECANNULATION WAS NECESSARY.

  Patient problems: Blood Loss; Discomfort; Extubate

  MAUDE report 8131638 ↗
• InjuryNov 12, 2018Disconnection; Disconnection

  ACCORDING TO THE REPORTER, WHILE ROUTINELY CLEANING THE INNER CANNULA A FRACTION WAS NOTICED IN THE UPPER PART OF THE CANNULA AND IS DISCONNECTED ON ONE SIDE OF THE WINGS. THE PATIENT WAS DE-CANNULATED AND RE-INTUBATED USING THE SAME TYPE OF THE DEVICE. IT WAS ALSO STATED THAT THE PATIENT DIED BUT NOT BECAUSE OF THE INCIDENT.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 8061203 ↗
• MalfunctionAug 31, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INNER CANNULA EXTENDED WELL PAST THE TRACHEOSTOMY TUBE CANNULA. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7836911 ↗
• MalfunctionAug 30, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE INNER CANNULA EXTENDS PAST THE TRACHEOSTOMY CANNULA. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7832836 ↗
• MalfunctionAug 30, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE¿S INNER CANNULA LENGTH WAS 4-6MM LONGER THAN TRACHEOSTOMY TUBE. CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7832814 ↗
• MalfunctionAug 30, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE INNER CANNULA EXTENDS PAST THE TRACHEOSTOMY CANNULA BY 5 MM OR 4-6 MM. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7832680 ↗
• MalfunctionAug 30, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INNER CANNULA EXTENDS PAST TRACHEOSTOMY CANNULA BY 4 TO 6 MILLIMETER. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7832400 ↗
• MalfunctionAug 30, 2018Defective Device; Defective Device

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INNER CANNULA EXTENDED PAST TRACHEAL CANNULA BY AT LEAST 4 MILLIMETER. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7832364 ↗
• MalfunctionMay 8, 2018Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE SNAP LOCK ON THE INNER CANNULA BROKE OFF. CUSTOMER REPORTED THE PATIENT WAS CONTINUING TO USE THE SAME TRACH AND THERE WAS NO RE-CANNULATION OR HARM. AND THEY HAVE SWITCHED OVER TO ANOTHER INNER CANNULA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7494175 ↗

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-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-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-1471-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• 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-1476-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton,
• Z-1463-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1467-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• 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-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
• Z-1480-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1488-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1466-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• 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

…and 8 more.