Purge Cassette
Medical device recall Z-1589-2026. Published in FDA’s Enforcement Report on Apr 8, 2026.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 8, 2026. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 33,107 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Increased risk of purge leaks with Generation 1 purge cassettes.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).
33,107 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1. Product Code: 0043-0003. GTIN: 00813502011135. All Purge Cassette batches/lot numbers are affected. 2. Product Code: 004334. GTIN: 00813502011029. All Purge Cassette batches/lot numbers are affected. 3. Product Code: 0043-0002. GTIN:…
Every code shown here, 1,996 characters
1. Product Code: 0043-0003. GTIN: 00813502011135. All Purge Cassette batches/lot numbers are affected. 2. Product Code: 004334. GTIN: 00813502011029. All Purge Cassette batches/lot numbers are affected. 3. Product Code: 0043-0002. GTIN: 00813502010510. All Purge Cassette batches/lot numbers are affected. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001 (GTIN: 00813502011999). 4. Product Code: 004413 (Customer facing code 005040). GTIN: 00813502010947. All Purge Cassette batches/lot numbers are affected. 5. Product Code: 0046-0011. GTIN: 04260113630273. All Purge Cassette batches/lot numbers are affected. 6. Product Code: 0048-0002. GTIN: 04260113630242. All Purge Cassette batches/lot numbers are affected. 7. Product Code: 0048-0002-BR. GTIN: 00813502011777. All Purge Cassette batches/lot numbers are affected. 8. Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). GTIN: 04260113630280. All Purge Cassette batches/lot numbers are affected. Finished Good Batch Numbers: 2024309080, 2024309083, 2024309085, 2024309088, 2024309091, 2024309095, 2024309099, 2024309104, 2024309109, 2024309112, 2024309333, 2024309335, 2024309339, 2024309343, 2024309346, 2024309347, 2024309349, 2024309350, 2024309351, 2024309355, 2024310812, 2024310813, 2024310815, 2024310817, 2024310818, 2024310819, 2024310823, 2024310824, 2024310825, 2024310826, 2024317648, 2024317649, 2024317650, 2024317651, 2024317652, 2024317653, 2024317654, 2024317655, 2024317657, 2024317660, 2024324585, 2024324587, 2024324588, 2024324589, 2024324591, 2024324592, 2024324593, 2024324594, 2024324595, 2024324596, 2024328613, 2024328619, 2024328620, 2024328622, 2024328625, 2024328629, 2024328634, 2024328636, 2024328640, 2024328641, 2024328666, 2024328670, 2024328675, 2024328692, 2024328706, 2024328716, 2024328718, 2024328720, 2024328722, 2024328723, 2024328737, 2024328741, 2024328743, 2024328749,…
FDA’s list runs to 345,183 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 18, 2026.
- FDA classified it on Mar 31, 2026.
- FDA’s Enforcement Report published it on Apr 8, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abiomed, Inc., of Danvers, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 345,183 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.