Prolaryn Plus 1.0 ccRecalls & reported problems
Merz North America, Inc. · Prolaryn® Plus is a sterile, latex-free, injectable implant used to treat vocal fold insufficiency, paralysis, and atrophy by augmenting (bulking) damaged vocal folds to improve voice production. It consists of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel, providing long-term structural support, with effects lasting up to one year. · Class 2 · Implant
- 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 00810235030853), received between Sep 8, 2026 and Sep 8, 2026 — classified as 1 malfunction.
1 other recall cover devices cleared under the same FDA submission (K013243); 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.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669922 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K013243. One submission often covers many models, so check the product and lot details in each record.
- Z-0368-2016 · Oct 26, 2015 · TerminatedPROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
Other Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) devices
- Biodesign G60285Cook Biotech Incorporated · POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)1 recall0 reports
- BIODESIGN G44451Cook Biotech Incorporated · POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)2 reports
- Biodesign G44839Cook Biotech Incorporated · POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.