Prolaryn Gel Injectable Implant 8602M0K5Recalls & reported problems
Merz North America, Inc. · Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat vocal fold insuffiency. Prolaryn Gel resorbs within a period of 3-6 months and is a temporary implant. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M2138602M0K55), received between Jan 28, 2026 and Jan 28, 2026 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K060815); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Autoimmune Disorder1
- Hypersensitivity/Allergic reaction1
- Necrosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A 2-YEAR-OLD MALE PATIENT. HE WAS INJECTED WITH 0.3 ML OF PROLARYN GEL, FOR A LARYNGEAL CLEFT. THE PATIENT DID FINE POST TREATMENT. AFTER THE PROLARYN GEL INJECTION, THE PATIENT EXPERIENCED LARYNGEAL NECROSIS. HE WENT HOME AND CAME BACK WITH STRIDOR AND DIFFICULTY BREATHING. THE PHYSICIAN TREATED THE PATIENT FOR CROUP FOR A DAY. THE PATIENT WENT HOME AND CAME BACK THE NEXT DAY AND HAD TO BE INCUBATED. HE WAS TAKEN TO THE OPERATING ROOM BY ANOTHER PHYSICIAN AND A SCOPE DEMONSTRATED LARYNGEAL NECROSIS. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 23-FEB-2026: THE EVENT'S POSSIBLE ALLERGIC REACTION AND LOCALIZED VASCULITIS WERE ADDED. THE PATIENT WAS INJECTED WITH PROLARYN GEL, INTO THE INTERARYTENOID SPACE DUE TO FINDINGS OF A TYPE 1 LARYNGEAL CLEFT, ON 17-DEC-2025. BATCH NUMBER WAS REPORTED AS A00219040 (EXPIRY DATE: 06-SEP-2027). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR PROLARYN GEL WAS CONFIRMED AS A00219040 (EXPIRY DATE: 06-SEP-2027). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THERE WERE NO INTRAOPERATIVE DIFFICULTIES WITH THE PR
Patient problems: Autoimmune Disorder; Hypersensitivity/Allergic reaction; Necrosis
MAUDE report 24200235 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060815. One submission often covers many models, so check the product and lot details in each record.
- Z-0367-2016 · Oct 26, 2015 · TerminatedPROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical pro
Other System, Vocal Cord Medialization devices
- Renú Voice 08-015-04-V04Cytophil, Inc. · System, Vocal Cord Medialization12 reports
- Renú Gel 08-015-00-V04Cytophil, Inc. · System, Vocal Cord Medialization3 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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