Lower riskMedical device recall · FDA · Published December 9, 2019
Abbott Medical Fast-Cath Hemostasis Introducer Recall: Wrong Size Dilators Risk
Abbott Medical recalls Fast-Cath Hemostasis Introducers with 8F instead of 8.5F dilators. These devices may cause improper vessel access during procedures. Affected batches include 6917183, 6950628, and 7099144.
“Abbott Medical Fast-Cath Hemostasis Introducer Recall: Wrong Size Dilators Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66396-abbott-medical-fast-cath-hemostasis-introducer-recall-wrong-size-dilators. Based on FDA recall #Z-0789-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0789-2020%22&limit=1).
The FDA announced on Dec. 9, 2019, that Abbott Medical is recalling Fast-Cath Hemostasis Introducer devices because some units contain incorrect sizing. The agency issued recall number Z-0789-2020 for the voluntary Class II action. Owners should contact Abbott Medical for a remedy.
How to tell if you have it
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143
Three lots of the Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices, according to the FDA record. The recall involves 380 devices distributed worldwide and in U.S. states including MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, as well as Canada and the Czech Republic.
Context
GovInfoNow's records show Abbott Medical has 15 other recalls on record since Oct. 14, 2019. Recent brand recalls include the May 12, 2026 Merlin PCS 365 software malfunction and the Oct. 6, 2025 Liberta RC DBS IPG communication loss issues. Other recent recalls of similar products include the March 18, 2026 Diversatek Viper 3-Stage Balloon Dilator incorrect part number risk, the March 18, 2026 Diversatek Viper 3-Stage Balloon Dilator incorrect inflation tag risk, and the March 11, 2026 Arrow Percutaneous Sheath Introducer incorrect adhesive manufacturing.
How to tell if you have this one
Check the batch numbers on the device: 6917183, 6950628, or 7099144. The product is labeled as Fast-Cath Hemostasis Introducer, 8.5F, 2.83 mm, REF 406143.
Brand
Abbott Medical
Product
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Batch
Look for batch numbers 6917183, 6950628, or 7099144 on the device's UDI label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Connecticut, Florida, Iowa, Massachusetts, Michigan, Mississippi, New Hampshire, New York, Ohio, Pennsylvania, Utah, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0789-2020 (December 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0789-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.